Diabetic Nephropathy Type 2NCT06690034
Relationship of Serum Zinc Level With Severity of Diabetic Nephropathy
An observational study of Diabetic Nephropathy Type 2, run by Assiut University.
Trial summary
Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production. However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy Type 2
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic kidney disease and Diabetic patient without kidney disease as a control
Who may be able to join
- Patients with diabetic kidney disease
Who cannot join
- patients on dialysis. Patient refuse to participate
- Other renal disease "lupus nephritis,GlomeruloNephritis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production.
However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease "CKD" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD
Read the detailed description
Chronic kidney disease (CKD) is an irreversible , progressive disease with high morbidity and mortality that occurs commonly in the general adult population, especially in people with diabetes and hypertension . It's defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause .
Diabetic kidney disease represents the most common cause of CKD in developed countries. Approximately 30% to 40% of diabetes mellitus (DM) subjects develop Diabetic kidney disease "DKD", and its presence significantly increases the risk for morbidity and mortality.
Zinc is an essential element and is the second most abundant divalent cation in the human body (2-4 g). It is mainly distributed in skeletal muscles (57%) and bone (29%) and acts as a cofactor for more than 300 enzymes. In addition, zinc is involved in the cellular mechanisms of proliferation, maintenance of structural integrity, and in the systemic regulation of the immune system . Zinc seems to have a potential role in kidney and body homeostasis in diabetic individuals which include stabilization of insulin hexamers and pancreatic insulin storage and improved glycemic control. Decreased zinc levels can impair insulin function and glucose metabolism, potentially worsening diabetes control and increasing the risk of kidney damage. Zinc is important for maintaining endothelial cell integrity and function. Endothelial dysfunction is a hallmark of DKD, and decreased zinc levels can exacerbate vascular complications associated with diabetes. Lower serum zinc levels have been associated with increased proteinuria, a common symptom of DKD. Proteinuria indicates kidney damage and is a predictor of disease progression. Zinc is involved in modulating the immune response. Deficiency can lead to a heightened inflammatory state, exacerbating kidney damage. Several studies underline the critical role of zinc in reducing oxidative stress levels, which is considered the common denominator of the mechanisms responsible for the progression of kidney disease. Zinc is a cofactor for various enzymes involved in heme synthesis and erythropoiesis
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- serum zinc level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Patient with Diabetic kidney disease according to KDIG | |
| group 2 | patients with diabetes without chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
zinc level
prevalence of hypozincemia in Diabetic kidney disease
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma kamal Eldin Mohamed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690034
- Sponsor's protocol ID
- Zinc and diabetic nephropathy
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Takao T, Yanagisawa H, Suka M, Yoshida Y, Onishi Y, Tahara T, Kikuchi T, Kushiyama A, Anai M, Takahashi K, Wakabayashi Sugawa S, Yamazaki H, Kawazu S, Iwamoto Y, Noda M, Kasuga M. Synergistic association of the copper/zinc ratio under inflammatory conditions with diabetic kidney disease in patients with type 2 diabetes: The Asahi Diabetes Complications Study. J Diabetes Investig. 2022 Feb;13(2):299-307. doi: 10.1111/jdi.13659. Epub 2021 Oct 7.
PubMed 34533892
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Serum Zinc Level With Severity of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06690034
- Acronym / sponsor ID
- Zinc and diabetic nephropathy
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- serum zinc level
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production.
However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease "CKD" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD
Detailed description
Chronic kidney disease (CKD) is an irreversible , progressive disease with high morbidity and mortality that occurs commonly in the general adult population, especially in people with diabetes and hypertension . It's defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause .
Diabetic kidney disease represents the most common cause of CKD in developed countries. Approximately 30% to 40% of diabetes mellitus (DM) subjects develop Diabetic kidney disease "DKD", and its presence significantly increases the risk for morbidity and mortality.
Zinc is an essential element and is the second most abundant divalent cation in the human body (2-4 g). It is mainly distributed in skeletal muscles (57%) and bone (29%) and acts as a cofactor for more than 300 enzymes. In addition, zinc is involved in the cellular mechanisms of proliferation, maintenance of structural integrity, and in the systemic regulation of the immune system . Zinc seems to have a potential role in kidney and body homeostasis in diabetic individuals which include stabilization of insulin hexamers and pancreatic insulin storage and improved glycemic control. Decreased zinc levels can impair insulin function and glucose metabolism, potentially worsening diabetes control and increasing the risk of kidney damage. Zinc is important for maintaining endothelial cell integrity and function. Endothelial dysfunction is a hallmark of DKD, and decreased zinc levels can exacerbate vascular complications associated with diabetes. Lower serum zinc levels have been associated with increased proteinuria, a common symptom of DKD. Proteinuria indicates kidney damage and is a predictor of disease progression. Zinc is involved in modulating the immune response. Deficiency can lead to a heightened inflammatory state, exacerbating kidney damage. Several studies underline the critical role of zinc in reducing oxidative stress levels, which is considered the common denominator of the mechanisms responsible for the progression of kidney disease. Zinc is a cofactor for various enzymes involved in heme synthesis and erythropoiesis
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Patient with Diabetic kidney disease according to KDIG |
| group 2 | – | –patients with diabetes without chronic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic kidney disease and Diabetic patient without kidney disease as a control
Key inclusion criteria (1 listed)
- Patients with diabetic kidney disease
Key exclusion criteria (2 listed)
- patients on dialysis. Patient refuse to participate
- Other renal disease "lupus nephritis,GlomeruloNephritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
zinc level
Time frame: baseline
prevalence of hypozincemia in Diabetic kidney disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Results publication: PubMed 34533892Takao T, Yanagisawa H, Suka M, Yoshida Y, Onishi Y, Tahara T, Kikuchi T, Kushiyama A, Anai M, Takahashi K, Wakabayashi Sugawa S, Yamazaki H, Kawazu S, Iwamoto Y, Noda M, Kasuga M. Synergistic association of the copper/zinc ratio under inflammatory conditions with diabetic kidney disease in patients with type 2 diabetes: The Asahi Diabetes Complications Study. J Diabetes Investig. 2022 Feb;13(2):299-307. doi: 10.1111/jdi.13659. Epub 2021 Oct 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy Type 2, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Mohamed Sayed, resident doctors (+2 01060342916, salma.16266351@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zinc level (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06690034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.